title: Pocket related complications in 163 patients receiving anticoagulation or dual antiplatelet therapy: D-Stat Hemostat versus standard of care.
abstract: BACKGROUND
  Pocket hematoma is a common complication after cardiac rhythm device implantation (CRDI) in patients receiving anticoagulation or dual antiplatelet therapy (DAPT). We sought to assess the safety and effectiveness of D-Stat Flowable Hemostat ([D-Stat]-a mixture of thrombin and collagen) in these patients.
  
  
  METHODS
  We conducted a prospective case control study and enrolled all patients admitted for CRDI receiving anticoagulation or DAPT. Participants received either D-Stat into the pectoral pocket as an adjunct to standard of care versus the standard of care (UC) alone. The primary endpoint was a composite of hematoma needing evacuation, and pocket infection.
  
  
  RESULTS
  We included a total of 163 patients (mean age 72 ± 8 years). 119 (73%) were male. 82 patients (50%) received D-stat and 81 (50%) usual care; 82 patients (50%) were treated with anticoagulation, 62 patients (38%) received DAPT, and 19 patients (12%) both. The primary endpoint occurred in 12/82 patients from the D-Stat group and 3/81 patients of the control group (14.6% versus 3.7%; p=0.03). The use of D-Stat tended for a higher incidence of pocket hematoma requiring evacuation (8.5% versus 2.4%; p=0.12), and an increased rate of pocket infections (6.1% versus 1.2%; p=0.21). Postoperative Immunoglobulin E levels (86 ± 147 IU/ml (D-Stat) versus 120 ± 231 IU/ml (UC)) and increase of C-reactive protein (D-Stat: ∆19 mg/l versus UC: 14 mg/l) were similar in both groups (p=0.26 and p=0.4, respectively).
  
  
  CONCLUSIONS
  Administration of D-Stat does not decrease the frequency of clinically relevant pocket hematomas. The observed rate of pocket infections in the D-Stat group is a matter of concern.
authors.affiliation: Department of Cardiology, Zentralklinik Bad Berka, Germany. m.ohlow.kar@zentralklinik-bad-berka.de
authors.forename: Marc-Alexander
authors.initials: MA
authors.lastname: Ohlow
authors.forename: Bernward
authors.initials: B
authors.lastname: Lauer
authors.forename: Bjoern
authors.initials: B
authors.lastname: Buchter
authors.forename: Matthias
authors.initials: M
authors.lastname: Schreiber
authors.forename: J Christoph
authors.initials: JC
authors.lastname: Geller
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000008:administration & dosage* / Q000009:adverse effects*; D016022:Case-Control Studies; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006406:Hematoma / Q000175:diagnosis / Q000453:epidemiology* / Q000209:etiology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010138:Pacemaker, Artificial / Q000009:adverse effects*; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects*; D011446:Prospective Studies; D012042:Registries; D059039:Standard of Care
chemical_list: D000925:Anticoagulants; D010975:Platelet Aggregation Inhibitors